This comment is in response to the possible requirement of a 3rd person needed in the room during sedation. This is an absolutely absurd recommendation. In fact it would actually increase potential problems and distractions.  I only allow sedation certified assistants with me in the room during a procedure and have never had the need for a 3rd person. This also is an increase in overhead to us and our patient. Properly trained personnel can do the job!!!!!!!!!

If a dentist wants a 3rd person in the operatory then they can do that. The mandateing of this is what I am totally opposed to.

 Jeff Blackburn

Section 18VAC60-21-291

Paragraph A, section 2, Line d:  medical has not been striked thru as in other sections

The last sentence states - "....a three-person team in the operatory during administration of Moderate sedation.”. This is incorrect per many national guidelines. It should state 3 individuals for Deep sedation. Therefore, the statement should be changed to reflect and be congruent with national guidelines.

.

This will be very simple.  I have a letter from Dr. James Toms, DDS, MS, FACD.  Dr. Toms serves as both the American Dental Association (ADA) and American Society of Dentists Anesthesiologists (ASDA) representative to the Amerian Society of Anesthesiologists (ASA) Task Force on the 2018 PRACTICE GUIDELINES FOR MODERATE PROCEDURAL SEDATION AND ANALGESIA.  The letter clearly states that the current two-person delivery of IV Moderate Conscious Sedation is NOT, I REPEAT, NOT being changed in the ADA nor ASA guidelines.  This letter is of public record and I have copied it here. PLEASE READ and appreciate the contents:               

April 25, 2018

As both the American Dental Association (ADA) and American Society of Dentists Anesthesiologists (ASDA) representative to the American Society of Anesthesiologists (ASA) Task Force on the 2018 Practice Guidelines for Moderate Procedural Sedation and Analgesia, I want to make exceedingly clear the intent and recommendations on specific language in a section of the Guidelines that is entitled “Availability of an Individual Responsible for Patient Monitoring” (pg. 443, second column).

In regards to the first bullet-point stipulated in the recommendation, where in the Guidelines it states,

• The individual responsible for monitoring the patient should be trained in the recognition of apnea and airway obstruction and be authorized to seek additional help.

We agree that this responsibility is fulfilled by any dental assistant with basic life support (BLS) training. Recognition of unconsciousness, apnea, airway obstruction, cardiac arrest, and the summoning of emergency medical services has been a long held competency in all current BLS certificate courses. A dental assistant, whether a registered dental assistant or otherwise, by virtue of BLS training and certification, can adequately perform these tasks.

Secondly, in regards to the subsequent bullet-point in the Guidelines which state,

• The designated individual should not be a member of the procedural team but may assist with minor, interruptible tasks once the patient’s level of sedation/analgesia and vital signs have stabilized, provided that adequate monitoring for the patient’s level of sedation is maintained.

The intent of this statement is to assure that at least one individual can assist the operating dentist in monitoring the moderately sedated patient AND concurrently be involved in minor, interruptible tasks such as suctioning, light-curing, tissue or tongue retraction, etc. Note carefully that this statement contains a “should” statement that is emphasizing that this individual should not be involved with the conduct of the procedure or surgery, but instead  act in a supplemental role that assists in patient monitoring and minor surgical/procedural tasks. Akin to Commission on Dental Accreditation (CODA) standards, a “should” statement is NOT a requirement, but rather presents an intent statement that implies “highly desirable, but not mandatory” as per CODA definition of terms.

We discussed this issue at great length at the ASA Task Force meetings to ensure that not only the dental profession can continue to practice to current ADA Moderate Sedation Guidelines which only require the presence of one other individual beside the operating dentist to assist in monitoring, but also that various other physician disciplines may operate in settings where the physician providing the moderate sedation can rely on the assistance of only one nurse, respiratory therapist, physician’s assistant, etc.

When I presented the draft document to the ADA for scrutiny, it was carefully examined for this exact issue and found to be congruent with existing 2017 ADA Guidelines, which explicitly state:

• At least one additional person trained in Basic Life Support for Healthcare Providers must be present in addition to the dentist.

With this understanding, the ADA gave expressed sponsorship and published endorsement of the 2018 ASA Guidelines as reinforcing and supporting past and present dental moderate sedation guidelines. The 2018 ASA Guidelines also concur with the American Academy of Pediatrics/American Academy of Pediatric Dentistry (AAP/AAPD) Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016 wherein the authors (one of which is also an author of the ASA Guidelines) state the following:

• Support personnel. The use of moderate sedation shall include
the provision of a person, in addition to the practitioner, whose
responsibility is to monitor appropriate physiologic parameters
and to assist in any supportive or resuscitation measures, if
required. This individual may also be responsible for assisting
with interruptible patient-related tasks of short duration, such
as holding an instrument or troubleshooting equipment. (AAP/AAPD p. 223)

To clarify even more and remove all ambiguity, the ASA Guideline document includes a “Summary of Recommendations” found in Appendix 1 (pg. 450, column two). Within the section found on page 450 and continuing on to page 451, within the subheading of “Availability of an Individual Responsible for Patient Monitoring,” language is clear in requiring only “a designated individual other than the practitioner performing the procedure is present to monitor the patient throughout the procedure.” Further, this individual is only responsible for monitoring the patient for signs of apnea and airway obstruction AND “may assist with minor, interruptible tasks.” The summary removes the “should” statement and for brevity and clarity, and stipulates only one additional person other than the practitioner needs to be present to assist in monitoring.

I wanted to assure you and others that the traditional dental model of only requiring one dental assistant while the operating dentist performs the procedure and administers moderate sedation is strongly supported by these ASA Guidelines. As a dental educator that provides a long-standing parenteral moderate sedation certification course for general practitioners and dental specialists from all over the nation, I made great efforts to promote the safety and continued use of this practice model to the ASA Task Force.

There is no effort underway or planned to require a third individual to be a sole monitor in moderate sedation practice in dentistry or medicine.

Please feel free to contact me at any time regarding this issue or any other issues involving patient safety, sedation, or anesthesia in general dental or specialty dental practice.

Respectfully,

Jimmy

James Tom DDS, MS, FACD
Dentist Anesthesiologist
Diplomate, American Dental Board of Anesthesiology
Diplomate, National Dental Board of Anesthesiology
President, American Society of Dentist Anesthesiologists
Associate Clinical Professor
Herman Ostrow School of Dentistry
University of Southern California
Division of Endodontics, General Practice Residency, and Orthodontics 925 W. 34th Street RM 4302
Los Angeles CA 90089
(213) 740-1081 jtom@usc.edu

Improving Access to Care for Dental Patients and Their Dentists

4411 Bee Ridge Road, #172 ? Sarasota, FL 34233 ? (phone) 312.624.9591 ? (fax) 773.304.9894 ? www.asdahq.org

I would like to make a technical comment, which will be separate from my professional comment, on this proposal.  I believe that it has been made unnecessarily difficult for the general public to ascertain the true changes that are being made to the regulations because there is currently the "Conforming rules to ADA guidelines on moderate sedation" changes that are also in their final stage and Governor's review.  These changes also affect the definitions in the proposal made that is up for commentary.  As such, it takes a careful review of the definitions minimal and moderate sedation to completely grasp the meaning of the proposed text that we have been asked to comment on.

As such, I would strongly encourage anyone to also read and incorporate the changes from "Conforming rules to ADA guidelines on moderate sedation" into their read of this proposal.  The final text is available here: http://townhall.virginia.gov/L/ViewXML.cfm?textid=12406

Thank you,

Jonathan L Wong, DMD, DADBA, DNDBA, FADSA *

Diplomate, American Dental Board of Anesthesia

Diplomate, National Dental Board of Anesthesia

Fellow, American Dental Society of Anesthesia

* The ADA does not recognize Dentist Anesthesiologists as specialists, therefore anesthesiology services are rendered as a general dentist with a general anesthesia permit.

The last sentence states -"...a three-person team in the operatory during administration of Moderate sedation.”. This is incorrect per many national guidelines. It should state 3 individuals for Deep sedation. Therefore, the statement should be changed to reflect and be congruent with national guidelines.

     I started providing oral conscious sedation in 2001-2002. At that time there were virtually no regulations except have a DDS or DMD degree. As more dentists began to use oral sedation regulations were developed to ensure safety of the patient. These regulations included courses designed in airway management as well as sedation procedures. I fully supported these regulations as patient safety cannot be jeopardized. Then in about 2011 or there about, more regulations were made. You had to have taken a 3 day course in sedation. Well because my original course was only 2 days I had to go back and retake a whole new course even though I had been doing oral sedation for 10 years. Also, because The Board could not guarantee that my 3 day course would be approved (it eventually was) I had to take another course by a dental anesthesiologist to insure it woul be accepted. Then came the Moderate Sedation Permit. I got the permit even though virtually all my sedations are "minimal sedation." I kept the permit so my patient 's would know that I went through the training to perform oral sedation and just in case The Board questions at some time if a patient was minimal or moderate. I can see where The Board is trying to go, that is eventually requiring any dentist doing any kind of sedation to have an IV permit. This would be totally absurd. I go all out (as most dentists) in making sure my patients under sedation are safe. It starts with a complete health history and medications they are on. The meds are run though Lexicomp for any possible interactions. I then do what I call a sedation pre-assessment which includes all vital signs, Malampati, tonsils, ASA classification, height, weight, BMI, as well as listening to their lungs. If there are any questions as to health concerns then I don't sedate or at minimum have a medical consult. I have all the required medical equipment. I use a pulse ox as well as capnography on each patient. You can see I go above and beyond what The Board requires. My patients apprecialte the fact that I offer oral sedation. It has benefited many patients who would not have had dentistry. I have invested many years and finances in oral sedation. Regualtions are good, I endorse most but the direction The Board is going (example requiring a 3 member team) is simply wrong. I sincerely hope The Board uses common sense in what they require. If you are heading in the direction of requiring all sedations to have an IV permit (which is what I have heard) I hope you change course. This would hurt so many patients who would benefit from oral sedation.

August 10th, 2018

Dear Virginia Board of Dentistry,

In reference to a copy of a letter I drafted to clarify some misconceptions regarding the mandate of a 3rd individual being present during the performance of moderate sedation in a dental office-based setting, I was asked to re-iterate some of the points that currently exist in not only the American Society of Anesthesiologists (ASA) 2018 Moderate Procedural Sedation and Analgesia Guidelines, but also in the newly affirmed American Academy of Pediatrics/American Academy of Pediatric Dentistry (AAP/AAPD) Guideline for Monitoring and Management of Pediatric Patients Before, During, and After Sedation for Diagnostic and Therapeutic Procedures: Update 2016.

I’ve maintained and continue to maintain that the intent and goals of all of the authors of the ASA 2018 Guidelines, which were comprised of not only dentists, but also pediatric physician anesthesiologists, a gastroenterologist, a cardiologist, an emergency medicine physician, an interventional radiologist, and other physician anesthesiologists, were to establish the two-person model of moderate sedation provision as the de facto standard of care, regardless of the setting. 

If the sedation provider truly intends for the patient to be in moderate sedation, in which patients purposefully respond to verbal stimulation and are awake during the procedure, you, in essence, already have three individuals present to ensure a minimum level of safety in monitoring and response: 1) The treating dentist, who is providing the sedation, 2) the dental assistant, who is monitoring the patient along with the treating dentist, and 3) the patient themself who is providing verbal and purposeful response to the dentist and assistant  during the procedure to indicate safe levels of sedation. 

I would respectfully urge the Virginia Board of Dentistry to reconsider the proposed language to mandate 3 individuals needed for the safe provision of moderate sedation as unnecessarily exceeding established and researched national guidelines.  Given the greater context of patients undergoing procedural moderate sedation in different healthcare venues outside of dentistry, the proposed mandate goes well beyond the intent of guideline committees specifically tasked to examine this matter.

As others have already stated, 3 individuals are required for the delivery of deep sedation and/or general anesthesia in a dental setting.  The current ASA, ASDA, and AAP/AAPD positions on deep sedation/general anesthesia for pediatric patients in dental settings require the third individual to be a dedicated and independent anesthesia provider (DDS, MD/DO, or CRNA) not involved in the conduct of the procedure. (see: https://www.csahq.org/docs/default-source/default-document-library/asa-statement-on-sedation-anesthesia-administration-in-dental-officebased-settings-(1).pdf?sfvrsn=0 and http://www.aapd.org/media/Policies_Guidelines/BP_AnesthesiaPersonnel.pdf )

Respectfully submitted by request,

Jimmy

James Tom DDS, MS, FACD

President, American Society of Dentist Anesthesiologists

Associate Professor

Herman Ostrow School of Dentitsry

University of Southern California

Thank you for the efforts to update the sedation and anesthesia guidelines for the Commonwealth of Virginia. Although I agree with a majority of the changes in the proposed text, there are some additional comments I wish the Board to consider.

First under the definitions in 18VAC60-21-10 I would ask that you consider the following changes:

1) Under section D, it may not be necessary to delete the definition of enteral.  Although moderate sedation is changing in order to not distinguish between enteral and parenteral routes of administration (and appropriately so), the definition of enteral may still come into play, especially when discussing maximum recommended doses in minimal sedation.

2) A point of clarification is that under Deep Sedation and General Anesthesia, the definitions mention "ventilator functions", this should state ventilatory function.  A ventilator is the mechanical machine that provides ventilatory support, the body has ventilatory and cardiovascular functions in these two definitions.

3) Please consider definining the "maximum recommended dose" as this will be a very debatable definition that practitioners will argue when defining the line between minimal and moderate sedation, as stated in 18VAC60-21-280 Section F 4. The ADA defines this in their guidelines as follows: "maximum FDA-recommended dose of a drug, as printed in FDA-approved labeling for unmonitored home use."  As a point of comment - this definition even by the ADA may be challenged by some providers as Xanax (alprazolam) allows for a higher FDA recommended maximum dose if titrated by the practitioner over time to the desired effect.  Some may choose to use the actual highest dosage allowed of 10mg per day, even though the FDA recommends dosing increases at intervals of 3-4 days and when increased should not be increased more than 1mg per day.

Under 18VAC60-21-260 General Provisions

1) Section K1 - it allows delegation of monitoring to " another dentists, anesthesiologists, or certified registered nurse anesthetist (CRNA)." In all other instances where a CRNA is mentioned, it is under the direction of the dentist, but in this single instance it is not.  According to the regulations, the CRNA must practice under the direction of a dentist with the appropriate level of sedation / anesthesia permit.  Therefore, a CRNA should also be under the direction of the dentist like the aforementioned assistant, hygienist, or nurse in this section.

2) Section M - Instead of "Special needs patients", this should read "Patients with Special Healthcare Needs". This is a matter of political correctness. In addition, the provisions here should also apply to pediatric patients that are uncooperative for IV placement prior to induction. Although this is mentioned in the section, the section heading makes it sound as if it only applies to Patients with Special Healthcare Needs.

18VAC60-21-279 Under section D - this section mentions the required equipment that shall be in working order and available, therefore item # 5 should not allow a pulse oximeter to not be available in the facility, therefore the section should simply read pulse oximeter.

18VAC60-21-290 Section 4.b - I would encourage the Board to consider changing the language of " at the timing that training occurred."  The ADA Guidelines for Teaching Pain Control and Sedation to Dentists and Dental Students have been developed to increase patient safety by ensuring that training and update / refresher courses meet the new standards, especially in terms of the competency in rescuing the airway and establishing parenteral access. The American Society of Anesthesiologists' 2018 Task Force on Procedural Sedation found that it was critical that a member of the team be competent in IV access. (http://anesthesiology.pubs.asahq.org/article.aspx?articleid=2670190) Practitioners should be held responsible for updating their training, especially in sedation and anesthesia as that person is responsible for the safety of the patient's life and the management of any complication that might arise.

Under 18VAC60-21-291

1) Section B.11 does not need to state parenteral administration any longer as this is all part of moderate sedation now and ECG should be required.

2) Section C - there is already a lot on input regarding this, but I would like the Board to consider verbiage such as this. " There shall be a two person team in the room with the patient at all times."  I believe the Board's intent was to ensure that two people were always present at the time, and as the AAPD and ADA guidelines state, the person monitoring the patient may have minor interruptible tasks. In many practices, this might include an immediately available third assistant to function as a "circulator" much like a circulating nurse in the OR.  Nevertheless, the established standard is a two person team. The only other explanation I have heard to justify this is the AAOMS Parameters of Care that state in Deep Sedation or GA that if the person monitoring the patient have no other responsibilities. However, this is Deep Sedation or GA.

Finally, it may be prudent for the Board to consider when a patient may be considered adequately recovered for these teams to leave the room with a designated staff member.  Unfortunately there have been numerous reports and associated morbidity and mortality when the sedation or anesthesia provider moves on to the next patient and leaves a patient with an "monitoring assistant." The ADA guidelines require that the patient return to a state of minimal sedation prior to leaving them with a dental assistant.  This may vary if the delegated individual were say an RN or a CRNA whom is licensed and has the adequate training to thoroughly monitor say the moderately sedated patient in recovery.

Thank you for your time and consideration of the above comments,

Jonathan L Wong, DMD, DADBA, DNDBA, FADSA

Diplomate, American Dental Board of Anesthesia *

Diplomate, National Dental Board of Anesthesia *

Fellow, American Dental Society of Anesthesiology *

*The ADA does not recognize Dentist Anesthesiologists as specialists, therefore anesthesiology services and expertise are rendered as a general dentist with a general anesthesia permit.

Under section 18VAC6O-21-260 K.2e there is no clarification on when, what type, and duration of vital sign monitoring is needed for minimal sedation. Please clarify. 

Dexmedetomidine can have deleterious effects on cardiorespiratory function. In a study of adult patients undergoing vascular surgery, Venn et al. reported that 18 of the 66 patients who received dexmedetomidine experienced adverse hemodynamic effects including hypotension.. Dr. Alex Carros

The National Fire Protection Association has had national standards on medical gas systems which are codified in the NFPA 99.  NFPA 99 has included dental offices performing any form of sedation, anesthesia, and anxiolysis since at least 1996. However, these rules have been seldomly enforced in dental offices.  In a discussion with members of the Virginia Society of Oral and Maxillofacial Surgeons, I was made aware that they have now made certification by an American Society of Sanitary Engineers (ASSE) 6030: medical gas verifier as part of their anesthesia self inspections for any new or rennovated gas system.  Given the unfortunate issues that have arisen in the past in Virginia, I would ask that the Board also consider these National Safety Standards when updating the sedation and anesthesia regulations.

In addition, the Dental Board has included by reference the American Academy of Pediatric Dentistry's (AAPD) Guidelines on Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures.  However, there is no reference to AAPD Policy on the Use of Deep Sedation and General Anesthesia in the Pediatric Dental Office.  In this policy it states, "The pediatric dentist is also responsible for establishing a safe environment that complies with local, state, and federal rules and regulations, as well as the Guideline for Monitoring and Management of Pediatric Patients During and After Sedation for Diagnostic and Therapeutic Procedures for the protection of the patient."  The NFPA 99 is the ANSI (Federal) standard for medical gas systems. In addition it is also adopted by reference in the International Plumbing Code and International Fire Code, which are adopted by the Statewide Building Code (State).  Local enforcement of this has been variable, but the policy set forth by the AAPD and now by VSOMS suggests that the dentist is responsible for ensuring this step toward compliance is followed.

In addition, such great concern for patient safety in dentistry from lack of compliance with NFPA 99 exists, that the NFPA has included a new chapter in the 2018 revision of the NFPA 99 code.  This chapter, Chapter 15, is solely about dental offices.

I would ask that the Board consider these issues when changing the regulations on sedation and anesthesia.  They may not be currently enforced in dentistry, but with the new 2018 changes they certainly will be in the future. I am uncertain if this is something that the Board of Dentistry wishes to address at this time while comment is open on these regulations, or if this should be left to Building Inspectors and Fire Marshals. Nevertheless, I believe it prudent to consider.

Sincerely,

Jonathan L Wong, DMD, DADBA, DNDBA, FADSA *

Diplomate, American Dental Board of Anesthesia

Diplomate, National Dental Board of Anesthesia

Fellow, American Dental Society of Anesthesia

* The ADA does not recognize Dentist Anesthesiologists as specialists, therefore anesthesiology services are rendered as a general dentist with a general anesthesia permit.

Under section 18VAC6O-21-260 K.2e and under Under section 18VAC6O-21-291 D.2e we need clarification as to how often the vital signs has to be recorded. You cant record blood pressure every second, the machine takes longer than that to take it. Why did you get rid of the every 5 minutes. It is impossible to do it every second. You need a time measure, every 5 min for instance. If you dont have a specified time measure you open yourself up to people doing it every 10 min, 15 min etc. 

Under section 18VAC6O-21-260 C required staffing. I agree with the other commenters. For this level of sedation 2 people is sufficient. Requiring 3 people is against other national guidelines and would mean the dental board of Virginia is establishing their own national guidelines.  The ada guidelines also only support a 2nd person not a 3rd.

Drs., I am writing to voice my strong opinion on what your proposal to limit our sedation options. Oral Sedation has been proven to be one of the safest modalities. The ADA guidelines and the commonwealth states don't have as restrictive guidlines that you are proposing. My whole team has been ACLS certified and I have gone to mulitiple DOCS courses to prepare us for oral conscious sedation. Our patients feel that this is a hugh benefit for them. Frankly, some of them wouldn't be seeing a dentist unless this is an option. These are the dental and needle phobic patients that depend on being sedated to have their work done.  I am taking time to write you for you to please reconsider your proposal. This would impact so many of my needy patients. 

Sincerely, Dr. Kim Kitchen 

Making it more difficult to provide minimal sedation will harm the patients who need it the most. We have many patients whose finances are tight, and who are terrified of the dentist. The cheapest method of sedation available is for them to pickup a valium at the local pharmacy and take it a few hours before their appointment. Many of these patients arrive still very fearful and need something further. This leaves us with 2 options. Option 1 is to add some nitrous, which allows us to quickly titrate them to a precise mild sedation level. It's safe, effective, fast, and expelled from the body quickly. Option 2 is to add more pills, which is harder to titrate, slow, and requires significant post op observation time. It also carries an increased risk of oversedation that is much more difficult to correct. This increases the overall cost of the visit, which eliminates dental care for many of the needy. Making mild sedation more expensive and difficult will decrease the overall publics oral health, increase dental ER visits, and reduce access to care. Please do not make VA the most difficult state in the US to offer minimal sedation.  

First, thank you for listening to my comments.  As a practicing general dentist who includes sedation dentistry as a part of my practice to help those in fear of the dentist, I implore you to reconsider the restrictions being proposed for MINIMAL sedation.  Having a fear of the dentist is like having a fear of snakes.  Could you imagine being in a den of slithering snakes and you hate snakes? That is what patients have described as the heart-pounding experience they have even from simply picking up the phone to call our office.  These patients are dying inside from their lack of oral care and all is compounded by systemic disease working in synergy to their early demise.  They need our help to SAFELY and EASILY gain access to care through sedation.  

Your proposal would require IV sedation equivalent training for perhaps only a quadrant of dentistry. I am a fan of continual learning, but it has to make sense.  Oral sedation is already proven to be the most safe method for helping phobic patients.  If the ADA guidelines are not this restrictive, why are Virginia's?  The best way to increase patient safety is not with arbitrary regulation and dosage requirements, but with adequate training, equipment, and patient monitoring.  How does IV sedation training equate to safer oral sedation administration?  My goal is minimal sedation if at all possible, but the patient has to be comfortable.  Nitrous oxide in addition to the sedative is key to realizing lower dosages of medications.   However, some patients just will need more than this proposal allows, and that is bad for the patient if this regulation passes. 

Tooth pain is real and so is the fear of the dentist.  Please do not pass these restrictions that will make it even harder for patients to receive and afford these services to improve their health. If dentists are required to attend these expensive courses for additional, unnecessary training, the cost is passed along to the patients.  Patients can be safe and healthy WITHOUT these hefty restrictions and extra fees.  My colleagues should be able to perform minimal sedation including nitrous oxide safely to improve access to care without arbitrary dose requirements.  Please reconsider, and thank you for your time.

Dear VA Dental Board,                                                                                                                 August 29, 2018

Regulations Governing the Practice of Dentistry [18 VAC 60 ? 21]

I am writing to voice my opposition to the proposed changes with oral conscious sedation. Our office has been oral sedation certified for almost 3 years and we have treated over 150 sedation patients without any incident. This is already a proven safe modality of treatment when the current regulations are followed.  These patients are people that have avoided dental treatment for years – sometimes decades - due to their great fear of dentistry and often of needles. The availability of oral sedation has made it possible for them to move forward with care to improve their health and eliminate infection.

 We generally use a combination of nitrous and Triazolam – generally about .5mg of Triazolam and sometimes up to.75mg if the patient is large. The proposed limiting of dosage and limiting sedation to just one medicine would limit the successfulness of sedation.  The dosage of Triazolam that is needed for sedation varies according to the patient’s size, other medicines they are taking and their reaction to the sedation medicine. However, by using nitrous in combination with Triazolam, we don’t have to use as much Triazolam.  By limiting the dosage or only allowing one of the meds, that will mean some patients are not adequately sedated to eliminate their anxiety about dental care and they will not have a comfortable, positive experience. 

Our patients mostly choose oral sedation because they don’t like an IV needle and the cost for oral sedation is significantly lower which makes access to dental care more affordable.  If there are concerns about any specific incidents, then that office should be visited to make sure the current guidelines are being adhered to. If more training is needed, then more training is a better way to increase patient safety rather than restricting the dosage of sedation meds. When the current guidelines are correctly followed, oral sedation is safe and allows access to care for many people that otherwise wouldn’t get dental care.

I would like to voice my feeling that this regulation would actually limit patient safety because people may not seek needed dental care if they have to have IV sedation. I feel these restrictive guidelines are not needed and do not increase patient safety and add a barrier to access of care for many people.

Thank You,

Dr Joseph McIntyre DDS

Smiles for Life Dental Care

115 Oakwood Drive

Bridgewater, VA 22812

540-828-2312

Dear VA Dental Board,

Regulations Governing the Practice of Dentistry [18 VAC 60   21]

I am writing to voice my opposition to the proposed changes with oral conscious sedation. Our office has been oral sedation certified for almost 3 years and we have treated over 150 sedation patients without any incident. This is already a proven safe modality of treatment when the current regulations are followed. These patients are people that have avoided dental treatment for years – sometimes decades - due to their great anxiety associated with dentistry and needles. I fear that without this option we will create an unnecessary barrier to care preventing patients from receiving the help they need. The availability of oral sedation has made it possible for many patients to move forward with care.

In our office, we generally use a combination of nitrous and Triazolam – generally about .5mg of Triazolam and sometimes up to.75mg if the patient is large. The proposed limiting of dosage and limiting sedation to just one medicine would limit the successfulness of sedation as one dose does not fit all patients. The dosage of Triazolam that is needed for sedation varies according to the patient’s size, other medicines they are taking and their reaction to the sedation medicine. However, by using nitrous in combination with Triazolam, we don’t have to use as much Triazolam. By limiting the dosage or only allowing one of the medications, that will mean some patients are not adequately sedated to eliminate their anxiety about dental care and they will not have a comfortable, positive experience.

Our patients mostly choose oral sedation over IV sedation because they don’t like an IV needle. Additionally the cost for oral sedation is significantly less than IV sedation allowing access to dental care to many who more are financially challenged. If there are concerns about any specific incidents, then that office should be visited to make sure the current guidelines are being adhered. A much better way to increase patient safety is to do more training rather than restricting the dosage of sedation medications. When the current guidelines are correctly followed, time has proven oral sedation is safe and allows access to care for many people that otherwise wouldn’t get dental care. If we hope to improve public dental health we should be aware of our patients needs and the barriers they face when seeking treatment.

I would like to voice my feeling that this regulation would actually limit patient safety because people may not seek needed dental care, perpetuating a state of unhealthiness if their only option is to have IV sedation. I feel these restrictive guidelines are not the answer, not needed, and do not increase patient safety.

Best,

Bryant Ash, DDS

Smiles for Life

115 Oakwood Dr. Bridgewater VA, 22812

To Whom it May Concern:

I would respectfully request that the board reconsider the suggested provision to minimal sedation. This new provision is more restrictive than in any other state & the ADA guidelines. Being able to provide our patients with minimal sedation greatly improves their access to care, especially for phobic patients.  Some patients simply need more than this proposed dosage restriction allows and fear will keep them from seeking the treatment they need. These patients will continue to bombard ERs and Urgent care as they avoid treatment due to fear and the excessive cost associated with IV and General Anesthesia. Oral sedation is incredibly safe & I believe that the best way to increase patient safety is via training, equipment, team, and monitoring, not with arbitrary dosage restrictions.

Thank you for your time and consideration

?

o Whom it May Concern:

I would respectfully request that the board reconsider the suggested provision to minimal sedation. This new provision is more restrictive than in any other state & the ADA guidelines. Being able to provide our patients with minimal sedation greatly improves their access to care, especially for phobic patients.  Some patients simply need more than this proposed dosage restriction allows and fear will keep them from seeking the treatment they need. These patients will continue to bombard ERs and Urgent care as they avoid treatment due to fear and the excessive cost associated with IV and General Anesthesia. Oral sedation is incredibly safe & I believe that the best way to increase patient safety is via training, equipment, team, and monitoring, not with arbitrary dosage restrictions.

Thank you for your time and consideration,

Nadia Armentrout DDS, FAGD

Regulations Governing the Practice of Dentistry [18 VAC 60 - 21]

I am writing to voice my opposition to the proposed changes with oral conscious sedation. Our office has been oral sedation certified for almost 3 years and we have treated over 150 sedation patients without any incident. This is already a proven safe modality of treatment when the current regulations are followed. These patients are people that have avoided dental treatment for years – sometimes decades - due to their great anxiety associated with dentistry and needles. I fear that without this option we will create an unnecessary barrier to care preventing patients from receiving the help they need. The availability of oral sedation has made it possible for many patients to move forward with care.

In our office, we generally use a combination of nitrous and Triazolam – generally about .5mg of Triazolam and sometimes up to.75mg if the patient is large. The proposed limiting of dosage and limiting sedation to just one medicine would limit the successfulness of sedation as one dose does not fit all patients. The dosage of Triazolam that is needed for sedation varies according to the patient’s size, other medicines they are taking and their reaction to the sedation medicine. However, by using nitrous in combination with Triazolam, we don’t have to use as much Triazolam. By limiting the dosage or only allowing one of the medications, that will mean some patients are not adequately sedated to eliminate their anxiety about dental care and they will not have a comfortable, positive experience.

Our patients mostly choose oral sedation over IV sedation because they don’t like an IV needle. Additionally the cost for oral sedation is significantly less than IV sedation allowing access to dental care to many who more are financially challenged. If there are concerns about any specific incidents, then that office should be visited to make sure the current guidelines are being adhered. A much better way to increase patient safety is to do more training rather than restricting the dosage of sedation medications. When the current guidelines are correctly followed, time has proven oral sedation is safe and allows access to care for many people that otherwise wouldn’t get dental care. If we hope to improve public dental health we should be aware of our patient’s needs and the barriers they face when seeking treatment.

I am opposed to the proposed guideline of having 3 people in the sedation operatory. We always have 2 people there but a third person is not needed. The ADA guidelines just recommend 2 people. There are always others in the office that are close by and could come to the room if needed.

I would like to voice my feeling that this regulation would actually limit patient safety because people may not seek needed dental care, perpetuating a state of unhealthiness if their only option is to have IV sedation. I feel these restrictive guidelines are not the answer, not needed, and do not increase patient safety.

Best,

Daniel Whiting DMD

Smiles for Life Dental Care

115 Oakwood Dr. Bridgewater VA, 22812

Regulations Governing the Practice of Dentistry [18 VAC 60 - 21]

I am writing to voice my opposition to the proposed changes with oral conscious sedation. Our office has been oral sedation certified for almost 3 years and we have treated over 150 sedation patients without any incident. This is already a proven safe modality of treatment when the current regulations are followed. These patients are people that have avoided dental treatment for years – sometimes decades - due to their great anxiety associated with dentistry and needles. I fear that without this option we will create an unnecessary barrier to care preventing patients from receiving the help they need. The availability of oral sedation has made it possible for many patients to move forward with care.

In our office, we generally use a combination of nitrous and Triazolam – generally about .5mg of Triazolam and sometimes up to.75mg if the patient is large. The proposed limiting of dosage and limiting sedation to just one medicine would limit the successfulness of sedation as one dose does not fit all patients. The dosage of Triazolam that is needed for sedation varies according to the patient’s size, other medicines they are taking and their reaction to the sedation medicine. However, by using nitrous in combination with Triazolam, we don’t have to use as much Triazolam. By limiting the dosage or only allowing one of the medications, that will mean some patients are not adequately sedated to eliminate their anxiety about dental care and they will not have a comfortable, positive experience.

Our patients mostly choose oral sedation over IV sedation because they don’t like an IV needle. Additionally the cost for oral sedation is significantly less than IV sedation allowing access to dental care to many who more are financially challenged. If there are concerns about any specific incidents, then that office should be visited to make sure the current guidelines are being adhered. A much better way to increase patient safety is to do more training rather than restricting the dosage of sedation medications. When the current guidelines are correctly followed, time has proven oral sedation is safe and allows access to care for many people that otherwise wouldn’t get dental care. If we hope to improve public dental health we should be aware of our patient’s needs and the barriers they face when seeking treatment.

I am opposed to the proposed guideline of having 3 people in the sedation operatory. We always have 2 people there but a third person is not needed. The ADA guidelines just recommend 2 people. There are always others in the office that are close by and could come to the room if needed.

I would like to voice my feeling that this regulation would actually limit patient safety because people may not seek needed dental care, perpetuating a state of unhealthiness if their only option is to have IV sedation. I feel these restrictive guidelines are not the answer, not needed, and do not increase patient safety.

Best,

Dr. Joseph McIntyre DDS

Smiles for Life Dental Care

115 Oakwood Dr. Bridgewater VA, 22812

This email is written for a request to reconsider the change in the provision for minimal sedation.  There are no states with a minimal sedation provision this restrictive.  The ADA guidelines, also, do not have a provision as restrictive.

This provision will take away an option to many patients who seek comfort and anxiety relief from the dental environment.  It will deter patients from seeking care for simple routine treatment which will eventually lead to more invasive and costly procedures in the future. 

I oppose the new proposal to limit minimal sedation by the board. I believe it compromises patient safety by restricting access to care for many anxious patients.

Dear Virginia Board of Dentistry, 

The concern of Virginia oral sedation dentists centers around the dosage restrictions being proposed for minimal sedation. Dentists would be limited to the MRD of a single sedative with or without nitrous. This dosage restriction was obviously copied from the American Dental Association's October 2016 sedation guidelines, which were the result of a great deal of controversy from dentists and stakeholders. The 2007 to 2015 iterations of the ADA guidelines contained a minimal sedation provision that allowed for up to 1.5x the MRD of a single sedative with or without nitrous, but the Virginia Board of Dentistry never bothered to adopt that provision during those eight years. No patients were harmed during that time with either minimal or moderate oral sedation by dentists who had formal training required by the board since 2005 (18 to 24 hours + ACLS + 4 hours q 2 years of renewal CE). And yet, one has to wonder what the political motivations are behind the current push to adopt this grossly over-restrictive proposal now.

It should be noted that some states have adopted an “unrestricted” minimal sedation concept that is consistent with the American Society of Anesthesiology’s own guidelines whereby the intended and resulting level of sedation governs. This has been implemented in Colorado, Illinois, Massachusetts, Minnesota, Nebraska, New York, Oregon, Rhode Island, South Carolina, Utah, Virginia (until now), and Washington when those dental boards revised their sedation rules over the past several years. I will elaborate below:

It should be noted that the full definition of "MRD" is "manufacturer's maximum recommended dose for at-home unmonitored use."

1. Manufacturer's: The common misconception here is that the MRD is set by the US FDA. It is not. In fact, the FDA's dosage limits appear on a chart called the MRTD, or maximum recommended therapeutic dose, which is actually MUCH higher than the MRD…higher than any of us would ever recommend or administer.
2. At-home: The MRD applies to at-home self-administration, not a dental or other healthcare office.
3. Unmonitored: This is most important. The MRD contemplates that the patient is unmonitored. Even during minimal sedation, this would not be standard of care. DOCS teaches that, even during minimal sedation, the patient would be monitored with pulse oximetry, an assistant would be present to assist the dentist with monitoring, the operatory would be equipped with standard of care equipment, and the appropriate unexpired emergency drugs would be readily available.
   1. Patients react differently to different drugs and a dentist must be able to adapt the drugs administered to the patient’s particular circumstances.
   2. Certain drugs may work better in combination with other agents, reducing the overall volume of sedatives required or permitting the time that a patient is under sedation to be reduced. For example, hydroxyzine administered together with a traditional short-half-life benzodiazepine sedative will permit more effective sedation at lower overall sedative volumes and will, in addition, help to reduce saliva volumes and gagging during procedures and increase sedative effectiveness in patients who are smokers.
   3. The ability to incrementally dose sedatives allows sedative levels to be kept to the minimum amount necessary. If a sedative can only be administered up to the MRD, dentists will have little option but to administer a bolus MRD just to achieve minimal sedation.
   4. The provision in the ADA guidelines dealing with supervision of sedated patients by Qualified Anesthesia Monitors, and the requirements for available facilities, including reversal agents, provide protection for patients.
   5. Allowing dentists to incrementally administer sedatives also protects patients by permitting the dentist to administer the minimum amount of medication required at each appointment, which may vary for each patient and on each day that that patient is sedated.
   6. NOTE:  DOCS adheres to a policy that the MRD should never be exceeded for pediatric patients (in Virginia, <13yo) under any circumstances. Patients under age 5yo should be referred to hospital-based dentistry, if necessary. 

The problem with dosage restrictions for minimal sedation is that they handcuff both the dentist and the patient. One size simply does not fit all. Sometimes 0.25mg of triazolam is enough to get Patient A into minimal sedation. Sometimes more than 0.5mg is necessary for Patient B to achieve minimal sedation.

A misconception about the DOCS incremental protocols is that they are intended to induce moderate or even deep sedation. This is simply not true. The incremental protocols are primarily intended to induce AND MAINTAIN minimal sedation. They were primarily created to assist dentists with long appointments for patients who have neglected their dental care for years or even decades. This is both safer and more cost-effective for the patient.

As such, DOCS training and the incremental protocols are intended to foster access to care...safe and effective dental care.

RECOMMENDATION:

While we agree that a maximum dose limitation is required, an overall maximum of the MRD of a single sedative may be too low for many otherwise healthy (ASA I and some ASA II) patients. An alternative suggestion would be to tie the dosages for the various widely-used sedatives to the patient’s body weight, such as:

1. Total overall prescribed dose of triazolam in mg (to a maximum of 2.0 mg) = body weight in lbs/100 (drug quotient factor for triazolam). This is only for ADULT patients (≥18yo) AND is rounded down AND is cut in half for medically-complex patients or patients over the age of 64;
   1. E.g. 180 lb patient (180 lb/100 qf) = 1.8 = 1.75 mg triazolam.
2. Total Overall Prescribed dose of lorazepam in mg (to a maximum of 8.0mg) = body weight in lbs/25 (drug quotient factor for lorazepam). This is only for ADULT patients (≥18yo) AND is rounded down AND is cut in half for medically-complex patients or patients over the age of 64. 
   1. E.g. 180 lb patient (180 lb/25 qf) = 7.2 = 7 mg triazolam.

Minimal Sedation is a vital component of modern general dentistry and the availability of affordable sedation options is absolutely necessary for a significant portion of the general public to be able to access dental services and maintain their oral health.

The goal of the Board must, therefore, be to establish a system which allows reasonable and cost-effective access to Minimal Sedation services for the patients who need them, while preserving reasonable standards of training for the dentist and dental auxiliaries to provide the safest services with reasonable requirements for the facilities in which the services are provided.

Thank you as always for your time and consideration. 

Respectfully submitted, 

John P. Bitting, Esq.

Regulatory and CE Counsel

DOCS Education

106 Lenora Street

Seattle, WA 98121

(206) 412-0089

(800) 727-4907 fax

John@DOCSeducation.com

The changes to the minimal sedation regulations are overburdensome and will only serve to limit access to care for anxiety ridden patients.

Higher than max recommended doses (which are dveloped for at home self administration) can be used successfully under the supervision of a licensed DDS or DMD to achieve minimal sedation, and should be based on the patient. Combinations of drugs can also be used successfuly to produce a minimum level of sedation with often times lower dosages of each drug. 

I oppose this regulation change.

Respectfully,

     It appears to me that the proposal that is being recommended has not bee thought out very well and is not supported by sound  data. Minimal sedation cannot be defined by an amount of drug; it is a state of consciousness. Some patients may take one amount and others may require a higher amount.. By setting a certain amount of drug you are hindering safety instead of promoting it. Adding hydroxyzine or N2O to triazolam allows us to use a smaller amount of triazolam.  Futhermore if one cannot use multiple doses, one will just give the higher dose when it may not be necessary. I have researched the sedation emergencies in Virginia and cannot find anywhere when safe protocols are followed there have been a death. Yes, there are a few cases where there have been a problem but it was not due to an amount of drug but instead an underlying medical condition. The same thing could happen with other drugs we use including lidocaine. So why then is Virginia looking to have one of the most restrictive regulation? What politics is behind this? I have been doing oral sedation safely since 2001-2002. I have always been in agreement with regulations to promote safety but cannot support this one. I have always gone above the Board in what I provide. By this proposed regulation you are robbing many patients in receiviing the dentistry they would otherwise not get. Please rethink this. Thank you.

To Whom It May Concern:

I am writing to request a review and reconsideration of the restrictions being considered for Oral Conscious Sedation in the State of Virginia. The proposed restrictions of oral conscious sedation for Dental procedures will have a detrimental effect upon the access and success of Dental care. “One size does NOT fit all”...limiting dosing to a single dose without the assistance of nitrous oxide will cause many patients to simply not achieve the level of Sedation they require for even basic dental care. It is inconsiderate and cold-hearted to say to a fearful patient “that is all I can give you...you will have to be brave from here.” Just as we would not perform general surgery upon a patient inadequately sedated, it is bad practice to do the same for an anxious, often damaged from previous bad experiences, patient. We will have a GREATER Dental health crisis on our hands if we cannot provide these patients the opportunity to receive adequate care. The teachers of Oral Conscious Sedation have gone above and beyond the requirements to teach and train dentists like myself to provide excellent service for fearful patients. They have research on their side. Unfortunate outcomes do happen, which require oversight and regulation...but to swing into an area of being the most restrictive on oral Sedation in all of the USA is not showing the State of Virginia Dentistry in the best light. We need to be courageous leaders bringing the best of dentistry to the community. Please reconsider this course and direction of action. Please do not allow singular interests or personal pride get in the way of safe dental practice for a whole class of patients in our communities. Thank you.